Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Intranasal nasal steroid sprays are the mainstay of treatment for chronic Eustachian tube dysfunction despite having little supportive evidence in the literature. A novel, commercially available nasal spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Age greater than or equal to 18 years old, <80 years old

• Chronic Eustachian tube dysfunction defined as:

• Symptoms in one or both ears > 3 months AND

• ETDQ-7 score >14.5 AND

• Type B, C, or As tympanometry

• Female subjects of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.

Exclusion Criteria:

• Age <18 years old

• Known history of otologic surgery (excluding myringotomy or myringotomy tubes)

• Use of any additional intranasal medication

• Tympanic membrane perforation

• Adhesive otitis media

• Cholesteatoma or significant retraction pocket

• Middle ear effusion

• Nasopharyngeal tumor

• Any history of head and neck cancer

• Any history of head and neck irradiation

• Any history of temporomandibular disorder or prior surgery to the temporomandibular joint

• Any medical condition that the investigator deems inappropriate for enrollment